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Public Private Partnerships at the NIH;
The Biomarkers Consortium (BC)
A PPP managed by FNIH
Partners are NIH, FDA, CMS, and private industry
Barbara B. Mittleman, M.D.
Director, NIH PPP Program
Bioinformatics Forum
March 4, 2009
BC Mission
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The Biomarkers Consortium endeavors
to discover, develop, and qualify
biological markers (biomarkers) to
support new drug development,
preventive medicine, and medical
diagnostics.
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Precompetitive Consortium
Biomarkers Consortium Partners
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Public
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Private
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NIH
FDA
CMS
PhRMA / BIO
Industry/ individual companies
Non-Profit
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Patient Advocacy Groups and Professional
Societies
Universities
FNIH
FNIH
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FNIH :
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501(c)(3) charitable foundation
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i.e., NOT the government!
Chartered by Congress in 1990
 Incorporated in 1996
 Mission, per Congress, is to support the
mission of the NIH
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Managing partner of the BC
BC Structure
Executive
Committee
SC
SC
SC
project
project
project
project
project
project
project
SC
project
Governance Structure
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Executive Committee (15 members)
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Steering Committees
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decision-making: advise FNIH Board on financial
commitments
3 NIH, 3 FDA, 3 pharmaceutical industry, 1 CMS, 1
biotech/diagnostics/imaging industry, 1 public,
3 (non-voting) FNIH
Content area focused : Neuroscience, Metabolic
Diseases, Oncology, Inflammation and Immunity
Identify and oversee specific project activities
Project Teams
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Implement projects
Intellectual Property
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Pre-competitive focus: BC strives not to
generate new IP, although it might happen
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Existing IP coming into PPPs will be
protected
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New IP will be handled in accordance with
Federal law and BC/PT specific agreements
Data/Sample Sharing and Access
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Must comply with human subjects protections
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Informed consents must be consistent with the
BC activities if samples are to be used or
distributed
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Precompetitive structure broad public
availability of data and samples, generation of
public resources
Confidentiality
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Pre-existing data, samples, and activities
contributed to BC activities will be considered to be
confidential if the donor requests (subject to
antitrust review)
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Confidentiality Agreements will be executed, as
needed
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No more than the minimum needed for Consortium
activities should be shared with project
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Aim is to maximize public availability, in accordance
with the project plan
Conflict of Interest
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FNIH is not NIH
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For NIH employees, these are official
duty activities
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FNIH rules require disclosure and
reporting
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Intention is to optimize fairness and
openness.
Antitrust Issues

Industry collaborations with more than a single
company may expose participants to antitrust
liability
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The Federal government is not liable
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Partnering with the government does not
immunize private partners against antitrust
liability
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BC rules comply with Federal antitrust law
BC Grantee/Contractor Selection
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FNIH is not NIH
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Awards are FNIH awards, not NIH awards
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FNIH/BC Conflict of Interest and Confidentiality
policies apply
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Solicitation and independent scientific review
conducted by FNIH
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Responders, awardees, and reviewers may be
BC members or not
Initial Projects
1) FDG-PET: qualification studies
Lymphoma
non-small cell lung cancer
2) Adiponectin in Type 2 Diabetes
data pooling to assess utility of
adiponectin as a marker of PPAR against
responsiveness
Initial Projects
3) PET ligand development:
developing and qualifying PET tools
for drug development
4) Circulating Tumor Cell identification
5) Other projects in development in OA,
depression, etc….
Important Links
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NIH PPP Program
http://ppp.od.nih.gov
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FNIH
www.fnih.org
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The Biomarkers Consortium
www.biomarkersconsortium.org